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OHRP Guidance - IRB Review of Clinical Trial Websites

Department of Health and Human Services (HHS)

Office for Human Research Protections (OHRP)

Guidance on Institutional Review Board Review of Clinical Trial Websites

Date: September 20, 2005

Scope:

This document provides guidance to Institutional Review Boards (IRBs) for the review of information provided to potential research subjects through clinical trial websites. This guidance, which applies to HHS-conducted or -supported research, describes the circumstances for which IRB review of clinical trial websites is required and provides some points to consider in the review process. It also describes the circumstances for which IRB review of clinical trial websites is not required.

NOTE: Some protocols described on clinical trial websites also may be subject to Food and Drug Administration (FDA) regulations. The reader is advised to consult with FDA about its regulatory requirements and guidance in this area.

Target Audience:

Research institutions, IRBs, investigators, and sponsors.

Introduction:

Websites, along with print and broadcast advertisements, are commonly used by investigators and institutions to recruit research subjects. In some cases, the information provided on these websites may constitute the earliest components of the informed consent process.

In May 2002, the HHS Office of Inspector General (OIG) issued a report, Clinical Trial Websites: A Promising Tool to Foster Informed Consent. The OIG report recommended that OHRP:
* Provide further guidance to IRBs on clinical trial websites.

* Clarify that risk and benefit information in trial listings is subject to IRB review and approval.

* Require IRB review of any prescreening used for specific trials.
The OIG report noted:
"Current guidance does not require IRB review if the clinical trial listing is limited to the following basic trial information: title, purpose of the study, protocol summary, basic eligibility criteria, study site location(s), and how to contact the study site for further information. This is a sound policy that we do not propose to change. However, some Web sites we reviewed provide more than the prescribed basic trial information mentioned in current guidance. In these instances it is unclear to IRBs whether review of the listing is required."
The OIG report also recommended that the review of pre-screening activities should address any relevant privacy and confidentiality issues.

Regulatory Background:

HHS regulations at 45 CFR 46.109(b) require that IRBs ensure that information given to subjects as part of informed consent meets the requirements specified in the regulations at 45 CFR 46.116.


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